Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL

Class I - Dangerous
🏥 Medical Devices Recalled: February 25, 2025 Stryker Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    5400-010-008I UDI-DI: 07613154340804, Lot Numbers: 2022100514 2023011113 2023012412 2023041712 2023052212 2023062714 2023110214 2024011112 2022100616 2023011612 2023012712 2023050812 2023053012 2023062914 2023110714 2024012912 2022101733 2023011712 2023021014 2023050912 2023061516 2023070314 2023111312 2024013112 2022101815 2023011912 2023021414 2023051212 2023061614 2023091914 2023111512 2024020712 2022102412 2023012312 2023041212 2023051713 2023062614 2023092112 2023112212 2024021215 2024030612 2024031112 2024042412 2024042514 2024073114 2024080116 2024080913 2024082014; 5400-010-008ITL UDI-DI: 07613327359503, Lot Numbers: 2022092712 2022112912 2023020613 2023042612 2023090412 2023112814 2024021414 2024032612 2022092912 2022113012 2023020712 2023050512 2023090612 2023112914 2024021512 2024040215 2022093014 2022120112 2023020812 2023051012 2023090714 2023113014 2024021612 2024040414 2022100432 2022120212 2023020913 2023051512 2023091312 2023120114 2024021912 2024041614 2022101212 2022120532 2023022112 2023051616 2023091414 2024010914 2024022112 2024041712 2022102114 2022120533 2023030614 2023052312 2023092214 2024011012 2024022212 2024051312 2022102612 2022120632 2023030712 2023052414 2023092732 2024011214 2024022312 2024051412 2022102714 2022120512 2023030812 2023052516 2023100314 2024011512 2024022714 2024052914 2022103132 2022120733 2023030912 2023060114 2023100414 2024011612 2024022712 2024052912 2022110712 2022120732 2023031012 2023060116 2023100932 2024011712 2024022814 2024053012 2022110812 2022120612 2023031412 2023060612 2023101712 2024011714 2024022812 2024060415 2022110332 2022120714 2023031612 2023060512 2023101914 2024011913 2024022914 2024060514 2022110912 2022120912 2023031714 2023060712 2023102415 2024012212 2024022912 2024061214 2022111032 2022121212 2023032012 2023061915 2023102514 2024012214 2024030112 2024061212 2022111012 2022121332 2023032112 2023062014 2023103114 2024012512 2024030614 2024061712 2022111033 2022121432 2023032312 2023062112 2023110112 2024012312 2024030714 2024061714 2022111432 2022121312 2023032732 2023062314 2023110314 2024012612 2024031212 2024062413 2022111412 2022121532 2023032832 2023062732 2023110612 2024013014 2024031312 2024062512 2022111433 2022121533 2023033132 2023062814 2023110732 2024020114 2024031414 2024070232 2022111612 2022121632 2023040332 2023071712 2023110813 2024020514 2024031514 2024070114 2022111632 2023011012 2023040433 2023072412 2023111414 2024020812 2024031912 2024070112 2022111712 2023013012 2023040532 2023080813 2023111614 2024020815 2024032012 2024070812 2022111732 2023013112 2023041314 2023081113 2023111714 2024020912 2024031914 2024070912 2022111812 2023020112 2023041912 2023082412 2023112016 2024020914 2024032114 2024080114 2022111832 2023020212 2023042415 2023083032 2023112315 2024021312 2024032214 2024080512 2022112615 2023020312 2023042512 2023090115 2023112712 2024021412 2024032614 2024080915 2024081214 2024081212 2024081612 2024082112 2024090632 2023050415
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Stryker Corporation
Reason for Recall:
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL

Product Codes/Lot Numbers:

5400-010-008I UDI-DI: 07613154340804, Lot Numbers: 2022100514 2023011113 2023012412 2023041712 2023052212 2023062714 2023110214 2024011112 2022100616 2023011612 2023012712 2023050812 2023053012 2023062914 2023110714 2024012912 2022101733 2023011712 2023021014 2023050912 2023061516 2023070314 2023111312 2024013112 2022101815 2023011912 2023021414 2023051212 2023061614 2023091914 2023111512 2024020712 2022102412 2023012312 2023041212 2023051713 2023062614 2023092112 2023112212 2024021215 2024030612 2024031112 2024042412 2024042514 2024073114 2024080116 2024080913 2024082014; 5400-010-008ITL UDI-DI: 07613327359503, Lot Numbers: 2022092712 2022112912 2023020613 2023042612 2023090412 2023112814 2024021414 2024032612 2022092912 2022113012 2023020712 2023050512 2023090612 2023112914 2024021512 2024040215 2022093014 2022120112 2023020812 2023051012 2023090714 2023113014 2024021612 2024040414 2022100432 2022120212 2023020913 2023051512 2023091312 2023120114 2024021912 2024041614 2022101212 2022120532 2023022112 2023051616 2023091414 2024010914 2024022112 2024041712 2022102114 2022120533 2023030614 2023052312 2023092214 2024011012 2024022212 2024051312 2022102612 2022120632 2023030712 2023052414 2023092732 2024011214 2024022312 2024051412 2022102714 2022120512 2023030812 2023052516 2023100314 2024011512 2024022714 2024052914 2022103132 2022120733 2023030912 2023060114 2023100414 2024011612 2024022712 2024052912 2022110712 2022120732 2023031012 2023060116 2023100932 2024011712 2024022814 2024053012 2022110812 2022120612 2023031412 2023060612 2023101712 2024011714 2024022812 2024060415 2022110332 2022120714 2023031612 2023060512 2023101914 2024011913 2024022914 2024060514 2022110912 2022120912 2023031714 2023060712 2023102415 2024012212 2024022912 2024061214 2022111032 2022121212 2023032012 2023061915 2023102514 2024012214 2024030112 2024061212 2022111012 2022121332 2023032112 2023062014 2023103114 2024012512 2024030614 2024061712 2022111033 2022121432 2023032312 2023062112 2023110112 2024012312 2024030714 2024061714 2022111432 2022121312 2023032732 2023062314 2023110314 2024012612 2024031212 2024062413 2022111412 2022121532 2023032832 2023062732 2023110612 2024013014 2024031312 2024062512 2022111433 2022121533 2023033132 2023062814 2023110732 2024020114 2024031414 2024070232 2022111612 2022121632 2023040332 2023071712 2023110813 2024020514 2024031514 2024070114 2022111632 2023011012 2023040433 2023072412 2023111414 2024020812 2024031912 2024070112 2022111712 2023013012 2023040532 2023080813 2023111614 2024020815 2024032012 2024070812 2022111732 2023013112 2023041314 2023081113 2023111714 2024020912 2024031914 2024070912 2022111812 2023020112 2023041912 2023082412 2023112016 2024020914 2024032114 2024080114 2022111832 2023020212 2023042415 2023083032 2023112315 2024021312 2024032214 2024080512 2022112615 2023020312 2023042512 2023090115 2023112712 2024021412 2024032614 2024080915 2024081214 2024081212 2024081612 2024082112 2024090632 2023050415

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1471-2025

Related Recalls

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

Oct 31, 2025 Other Medical Devices Nationwide View Details →